Questions have arisen with regard to the investigation and market approval of the anti-malarial drug mefloquine. I understand that you intend to undertake an audit of the Health Protection Branch (HPB) at the Department of Health. I recommend that your work include an audit of the decision-making and compliance with the law for mefloquine. May I suggest that your audit take into account the following facts:

The drug was illegally administered to Canadian troops bound for Somalia prior to its licensing. DND was part of the mefloquine Safety Monitoring Study.

DND's use of the drug provided the only opportunity for Canadian doctors to directly observe the drug's possible adverse effects. HPB ought to have shown a keen interest in the findings of DND's participation in the Safety Monitoring Study. Sadly that was not the case.

Did the department monitor the Study and critically assess its findings prior to the licensing of the drug? Were there similar problems amongst other participants in the Study? Did other participants treat the legal requirements of the Safety Monitoring Study as lightly as did the Department of National Defence? Did HPB take any action against those participants who used the drug illegally prior to licensing and who undermined the pre-licensing study?

Even after the problems associated with DND's use of mefloquine became highly publicized, HPB showed little or no interest in DND's illegal use of the drug or its failure to comply with the Safety Monitoring Study protocol. In fact, HPB has since hired the officer at DND who was responsible for the illegal use of the drug and who refused to comply with the requirements of the Food and Drug Act.